BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELENIA FFDM MAMMOGRAPHY SYSTEM

    MDR report key: 1007960 · Received March 4, 2008

    Report

    Report Number
    1220984-2008-00001
    Event Type
    Other
    Date Received
    March 4, 2008
    Date of Event
    December 13, 2007
    Report Date
    March 3, 2008
    Manufacturer
    HOLOGIC INC.
    Product Code
    IZH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: ON FEB 4, 2008, THE SELENIA MAMMOGRAPHY SYSTEM WAS EVALUATED BY THE MAMMOGRAPHY TECHNOLOGIST AND WAS FOUND TO BE FUNCTIONING NORMALLY. AN HOLOGIC TECHNICAL SUPPORT ENGINEER REVIEWED THE DYNAMIC LOG FILES FROM THE SYSTEM. THIS LOG RECORDS SYSTEM OPERATION EVERY FEW SECONDS. THE LOG FOR ALL VIEW STUDIES OF THIS PARTICULAR PT RECORDED IN LATE 2007, SHOW NO ANOMALIES IN SYSTEM OPERATION. HOLOGIC COULD NOT CONFIRM THAT INADVERTENT MOVEMENT OF THE MAMMOGRAPHY SYSTEM OCCURRED DURING THE PT'S EXAMINATION ON THE SAME DAY. THE TECHNOLOGIST REPORTED THAT SHE DID NOT OBSERVE ANY INADVERTENT MOTION OF THE MAMMOGRAPHY SYSTEM WHILE WITH THIS PT. THE TECHNOLOGIST ALSO REPORTED THAT THE PT NEVER INDICATED TO HER THAT INADVERTENT MOVEMENT OF THE MAMMOGRAPHY SYSTEM OCCURRED OR THAT SHE (PT) HAD BEEN INJURED. THIS SITE HAS CONTINUED TO USE THE MAMMOGRAPHY SYSTEM WITHOUT INCIDENT. HOLOGIC FIELD ENGINEER EVALUATED THE MAMMOGRAPHY SYSTEM ON MARCH 3, 2008, AND FOUND IT TO BE FUNCTIONING PROPERLY.

    Description of Event or Problem · 1

    IN 2008, A PT INFORMED NORTH COUNTRY HOSPITAL THAT SHE HAD BEEN INJURED WHILE UNDERGOING A MAMMOGRAM AT THEIR FACILITY. SHE STATED THAT SHE HAS A HERNIATED DISC IN HER NECK, CAUSED BY AN INCIDENT THAT OCCURRED WHILE AT THEIR FACILITY. SHE REPORTED THAT DURING A MAMMOGRAM IN "2008", THE SELENIA MAMMOGRAPHY SYSTEM INADVERTENTLY MOVED UPWARD WHILE SHE WAS UNDER COMPRESSION. SHE REPORTED THAT THE SYSTEM LIFTED HER UP ON HER TOES. THE PT DID NOT REPORT THIS EVENT TO THE TECHNOLOGIST DURING THE EXAM OR IMMEDIATELY FOLLOWING THE EXAM. THE TECH REPORTED THAT SHE DID NOT OBSERVE ANY INADVERTENT MOTION OF THE MAMMOGRAPHY SYSTEM WHILE WITH THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELENIA FFDM MAMMOGRAPHY SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM IZH HOLOGIC INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other